Glaucoma Implant Device

• US 20070118066A1
• Filed: 11/21/2006
• Published: 05/24/2007
• Est. Priority Date: 12/03/2004
• Status: Active Grant

• Current Assignee: InnFocus, Inc. (Santen Pharmaceutical Company Limited)
• Original Assignee: Innfocus, LLC
• Inventors: Pinchuk, Leonard, Parel, Jean-Marie, Fantes, Francisco
• Granted Patent: US 7,837,644 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002

Abstract

An aqueous humor drainage device having an elongate structure that provides a fluid passageway for diverting aqueous humor from the anterior chamber of the eye. The device is formed from a biocompatible soft polymeric material with a hardness less than Shore 80A. Preferably, the polymeric material includes polyisobutylene and a glassy segment. The device preferably includes at least one fixation member that extends from the elongate structure. In one embodiment, the fixation member is realized by a tab that is spaced apart from the two ends of the elongate structure. In another embodiment, the fixation member is realized by a pair of tines that extend in traverse directions relative to the central axis of the elongate structure. The tines are spaced apart for positioning on opposite sides of the sclera of the eye during use.

Claims

1. An aqueous humor drainage device comprising:

an elongate duct structure that provides a fluid passageway for diverting aqueous humor from the anterior chamber of the eye, said elongate duct structure formed of a polymeric material with a hardness less than Shore 80A.

2. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material is loaded with at least one therapeutic agent that minimizes fibrosis of ocular tissue.

3. An aqueous humor drainage device according to claim 2, wherein:

said at least on therapeutic agent is selected from the group including;

Visudyne, Lucentis (rhuFab V2 AMD), Combretastatin A4 Prodrug, SnET2, H8, VEGF Trap, Cand5, LS 11 (Taporfin Sodium), AdPEDF, RetinoStat, Integrin, Panzem, Retaane, Anecortave Acetate, VEGFR-1 mRNA, ARGENT cell-signalling technology, Angiotensin II Inhibitor, Accutane for Blindness, Macugen (PEGylated aptamer), PTAMD, Optrin, AK-1003, NX 1838, Antagonists of avb3 and 5, Neovastat, Eos 200-F and any other VEGF inhibitor, mitomycin C, 5-fluorouracil, corticosteroids (corticosteroid triamcinolone acetonide is most common), modified toxins, methotrexate, adriamycin, radionuclides, protein kinase inhibitors (including staurosporin, which is a protein kinase C inhibitor, as well as a diindoloalkaloids and stimulators of the production or activation of TGF-beta, including tamoxifen and derivatives of functional equivalents, e.g., plasmin, heparin, compounds capable of reducing the level or inactivating the lipoprotein Lp(a) or the glycoprotein apolipoprotein(a) thereof), nitric oxide releasing compounds (e.g., nitroglycerin) or analogs or functional equivalents thereof, paclitaxel or analogs or functional equivalents, inhibitors of specific enzymes (such as the nuclear enzyme DNA topoisomerase II and DAN polymerase, RNA polyermase, adenl guanyl cyclase), superoxide dismutase inhibitors, terminal deoxynucleotidyl-transferas, reverse transcriptase, antisense oligonucleotides that suppress cell proliferation, angiogenesis inhibitors (e.g., endostatin, angiostatin and squalamine), rapamycin, cerivastatin, and flavopiridol and suramin and the like, peptidic or mimetic inhibitors (i.e., antagonists, agonists, or competitive or non-competitive inhibitors of cellular factors that may trigger proliferation of cells, pericytes (e.g., cytokines, for example, interleukins such as IL-1), growth factors (for example, PDGF, TGF-alpha or -beta, tumor necrosis factor, smooth muscle- and endothelioal-derived growth factors such as endothelin or FGF), homing receptors (for example, for platelets or leukocytes), and extracellular matrix receptors (for example, integrins), subfragments of heparin, triazolopyrimidine (for example, trapidil , which is a PDGF antagonist), lovastatin; and

prostaglandins E1 or I2.

4. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material comprises polyisobutylene and a glassy segment.

5. An aqueous humor drainage device according to claim 4, wherein:

said glassy segment does not contain any cleavable group which will release in the presence of body fluid inside the human eye and cause toxic side effects and cell encapsulation.

6. An aqueous humor drainage device according to claim 4, wherein:

said glassy segment comprises a vinyl aromatic polymer.

7. An aqueous humor drainage device according to claim 6, wherein:

said vinyl aromatic polymer comprises at least one of styrene and α

-methylstyrene.

8. An aqueous humor drainage device according to claim 4, wherein:

said glassy segment comprises a methacrylate polymer.

9. An aqueous humor drainage device according to claim 8, wherein:

said methactylate polymer comprises at least one of methylmethacrylate, ethyl methacrylate, and hydroxymethalcrylate.

10. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material has a general block structure with a central elastomeric polyolefinic block and thermoplastic end blocks.

11. An aqueous humor drainage device according to claim 10, wherein:

said polymeric material comprises a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene.

12. An aqueous humor drainage device according to claim 1, wherein:

said polymeric material has a general block structure selected from one of the following;

a) BAB or ABA,

b) B(AB)n or a(BA)n, and

c) X−

(AB)n or X−

(BA)n;

where A is an elastomeric polyolefinic block, B is a thermoplastic block, n is a positive whole number and X is a starting seed molecule.

13. An aqueous drainage device according to claim 12, wherein:

said material comprises one of a star-shaped block copolymer (where n=3 or more) and multi-dendrite-shaped block copolymer.

14. An aqueous humor drainage device according to claim 1, wherein:

said elongate duct structure defines a lumen channel having a diameter between 0.002 in and 0.006 in.

15. An aqueous humor drainage device according to claim 1, wherein:

said elongate duct structure has an outside diameter less than 0.02 inches.

16. An aqueous humor drainage device according to claim 1, further comprising:

at least one fixation member that extends from said elongate duct structure.

17. An aqueous humor drainage device according to claim 16, wherein:

said at least one fixation member comprises a tab that extends radially outward from said elongate structure.

18. An aqueous humor drainage device according to claim 16, wherein:

said at least one fixation member comprises a pair of tines that extend in directions transverse to the central axis of said elongate duct structure.

19. An aqueous humor drainage device according to claim 18, wherein:

said pair of tines are spaced apart along the length of said elongate duct structure for disposition about opposite sides of a tissue structure of the eye.

20. An aqueous humor drainage device according to claim 19, wherein:

said tissue structure comprises the sclera of the eye.

21. An aqueous humor drainage device comprising:

an elongate solid tubular structure formed of a polymeric material with a hardness less than Shore 80A, wherein the solid tubular structure is compressible under elevated ocular pressure to provide a fluid passageway for diverting aqueous humor from the anterior chamber of the eye.